MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT4 III; RADIOIMMUNOASSAY, FREE THYROXINE

Model Number FT4 G3

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/14/2022

Event Type  malfunction  

Event Description

The initial reporter received questionable elecsys ft4 iii assay, elecsys ft3 iii and elecsys ft3 iii ver.2, and elecsys anti-tshr immunoassay ver.2 results for one patient sample tested on the customer's cobas e411 rack with serial number (b)(4), the investigation site's cobas 8000 e 411 module with serial number (b)(4).This mdr is for the ft4 iii assay.Refer to: medwatch with - patient identifier (b)(6) for the ft3 iii v2 assay.Medwatch with - patient identifier (b)(6) for the ft3 iii assay.Medwatch with - patient identifier (b)(6) for the anti-tshr assay.The initial result was not reported outside of the laboratory.The reporter suspected non-specific interference in the roche thyroid assays.The patient sample was sent to the investigation site and an outsourced laboratory that uses a fujirebio lumipulse analyzer.The ft4 iii reagent lot used in the customer site's e 411 and its expiration date were requested but not provided.The ft4 iii reagent lot used in the investigator site's e 411 is 623234 with an expiration date of 30-apr-2023.

Manufacturer Narrative

The patient sample was received for investigation.

Manufacturer Narrative

The patient sample was received for investigation.The investigation confirmed the high ft4 and ft3 and anti-tshr results obtained by the customer.The results of the different test versions were comparable.The ft4 iii and ft4 iv concentration values were both above the reference range but these values clearly showed differences.The investigation determined an interfering factor against ruthenium (ru) label in the ft3 and ft4 assays.The same interfering factor most likely also caused the falsely elevated value of the anti-tshr assay.A combination of an interfering factor against ft3 antibody/idiotype was also observed in the patient sample.Product labeling states "in rare cases, interference due to extremely high titers of antibodies to test specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination, and other findings." the investigation did not identify a product problem.

• Brand Name: ELECSYS FT4 III
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16033926
• MDR Text Key: 308384203
• Report Number: 1823260-2022-04150
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FT4 G3
• Device Catalogue Number: 07976836190
• Device Lot Number: ASKU, 623234
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1